An Assessment of State Board of Pharmacy Legal Documents for Public Health Emergency Preparedness

INTRODUCTION

The 2005 hurricane season revealed major challenges for medical and public health disaster response systems. In steady succession, Hurricanes Dennis (July), Katrina (August), Rita (September), and Wilma (October) caused significant disruption to the Gulf Coast region, displacing more than one million people¹ and resulting in more than 2100 deaths and $USD 112 billion in damage.² The cumulative effect of these natural phenomena severely strained existing medical and public health infrastructure, where patient access to chronic care services (including medications)³ became a principal concern.¹

In response to the vulnerabilities revealed by the Gulf Coast storms of 2005, the National Association of Boards of Pharmacy (NABP) convened a task force to address the pharmacy-related aspects of the response.⁴ The task force observed that, though state boards of pharmacy routinely facilitated access to substantial amounts of web-based resources such as license verification and renewal, pharmacy laws, and continuing education requirements, little information was readily available regarding statutory or regulatory requirements governing pharmacy services in times of disaster.⁴ As a result, the task force drafted the “Emergency and Disaster Preparedness and Response Planning Guide for Boards of Pharmacy.”⁵ By offering draft language suitable for incorporation into state pharmacy practice acts, the guide provided a statutory and regulatory framework for states to use to proactively prepare for future disasters.

It is not uncommon for executive authorities (ie, state boards of pharmacy or state governors) to issue emergency declarations suspending, adopting, or invoking specific rules in times of disaster.^6-9 In lieu of instituting emergency measures post hoc, such authorities recommend that states establish legal measures a priori,¹⁰ allowing the pharmacy and health care communities the benefit of proactively anticipating the regulatory environment when emergency rules are invoked. Since 2006, state boards of pharmacy have had access to guide recommendations, including the eight Rules for Public Health Emergencies (RPHE) in the Model Pharmacy Practice Act.⁵ At this point, however, the extent to which the RPHE have been incorporated into state pharmacy legal documents is unknown. As in the aftermath of the 2005 hurricane disasters, the actuating question for state boards of pharmacy remained in 2015: is adequate pharmacy-specific legal documentation currently instituted to facilitate the provision of pharmacy services during a disaster?

The purpose of this research, therefore, was to assess the pharmaceutical preparedness of US states and commonwealth territories by evaluating pharmacy regulatory documents for the presence of the eight recommended RPHE.

DISCUSSION

Prior to this research, the extent to which RPHE were incorporated into state pharmacy legal documents was largely unknown. Our study suggests that most states are without adequate legal documentation to facilitate the provision of pharmacy services in disaster. Data show that 49 of 54 US states and territories adopted less than half the recommended RPHE, and of these, 20 adopted none of the RPHE. Other research suggests similar results.^14,15 In a cross-sectional study of state board of pharmacy representatives, Lowe analyzed information regarding the presence of disaster-specific regulations in state pharmacy practice acts.¹⁵ While only 18 states reported useful information, data indicated that disaster-specific legal measures were inconsistently adopted among boards of pharmacy and would likely remain unchanged in the foreseeable future.¹⁵

To illustrate the real and practical difficulties that can manifest as a result of inadequate legal support, a report by the Centers for Disease Control and Prevention (CDC) suggests that while public health preparedness has improved since 2001, state governments continue to face operational challenges with expediting the deployment of assets from local, state, and federal medication caches.^14,16 The lack of adequacy and consistency in disaster-specific regulations may increase confusion among licensed pharmacists and inherently discourage volunteer participation in disaster-related activities.¹⁵ For these reasons (and considering that pharmacists must prepare for and pass jurisprudence examinations in each state for licensure), we strongly encourage states without disaster-specific pharmacy statutes to incorporate appropriate legal language into their pharmacy practice acts.¹⁷ Minimally, states should have adequate regulatory language promulgated by boards of pharmacy (ie, NABP RPHE) that address policies and procedures governing pharmacy practice in disasters.¹⁷ Until that point, inadequate state-level legal support for disaster-related responsibilities will continue to negatively impact patient safety .^18,19

Although practical disaster-specific considerations (eg, record-keeping, medication disposal, refill dispensing, and emergency prescription drug order processing) for pharmacist volunteers depend on legal mechanisms within each state,²⁰ federal-level measures can be used to protect volunteers from liability.^20,21 For example, the Public Readiness and Emergency Preparedness (PREP) Act can be invoked by the US Secretary of Health and Human Services to provide immunity from problems arising from the use of medical countermeasures dispensed by pharmacists (and other authorized personnel).^20,21 The PREP Act also provides a regulatory mechanism to conduct basic, clinical, and administrative research on medical countermeasures.²¹ Emergency Use Authorizations (EUA) are granted by the Food and Drug Administration (FDA) commissioner and provide for the emergency use of unapproved medical products and approved medical products for unapproved indications.²¹ Each EUA is associated with unique provisions governing its issuance and is effective until terminated by the FDA.²¹ The Shelf Life Extension Program (SLEP) is a mechanism used in conjunction with an EUA to promote greater access to medical countermeasures during disasters. Once labels expire, medical countermeasures are tested for potency to determine their eligibility for extended shelf life.²⁰ Investigational New Drug and Investigational Device Exemption applications can be employed in disasters to facilitate use of unapproved medications or medication devices.²¹ Like the SLEP, these applications are typically accompanied by the issuance of an EUA.²¹ While these legal tools serve important functions for pharmacist volunteers, protective mechanisms are critical in federally-declared disasters. Their use for point-of-dispensing administrative concerns, which are governed by individual state jurisdictions, are of limited significance.

Interestingly, state disaster declarations and RPHE adoption trend closely when analyzed by NABP district (Figure 2), suggesting that rule adoption may be a function of geographic location and disaster occurrence (Spearman r=0.32, p=0.02). In terms of the number of RPHE adopted by boards of pharmacy, NABP District 3, which encompasses the southeastern states and Caribbean territories, is best prepared compared to other districts to expedite a pharmaceutical response to disaster (p=0.001). This relatively heightened attentiveness to pharmaceutical preparedness may be a result of the potential for sociomedical sequelae associated with seasonal recurrence of hurricanes and subsequent weather (including wind and tornado damage, hail showers, and flooding).

In the aftermath of Hurricane Katrina, for instance, several southern states including Alabama instituted legal measures to accommodate the prescription needs of a large influx of disaster refugees.^6,9 Some of these measures allowed pharmacists to issue 30-day refill quantities,⁶ granted emergency temporary pharmacist licenses,⁹ reactivated inactive pharmacist licenses,⁹ and allowed remote pharmacies to provide services to the population,⁹ among others. While District 3 adopted a significantly greater number of RPHE than other districts, District 6 was associated with the most state disaster declarations (p<0.0001, Figure 2), indicating that despite closely parallel trends between disasters and RPHE, districts that experienced the most disasters did not necessarily adopt the most RPHE.

Among the eight RPHE, Rule 2 (pharmacies should establish policies and procedures for reporting disasters to the state board within 10 days of occurrence⁵) has been adopted by the most state boards of pharmacy (p=0.03), followed by Rule 5 (pharmacist, pharmacy technicians, and wholesalers not licensed in the state in which the disaster occurs may dispense drugs in disaster areas as long as (a) the licenses can be verified and found to be in good standing, and (b) the professionals are engaged in disaster relief efforts,⁵ Figure 3). Considering the predominance of online license verification tools available through board of pharmacy websites and the importance of disaster notification and license information for the various boards and their constituents, these findings may be indicative of the importance of communication and information sharing, especially during times of disaster.

Twenty-one states have no provision for public health emergency refill dispensing, and fifteen states limit refill quantities to a 72-hour emergency supply (Figure 4), a finding consistent with other research.¹⁷ The importance of instituting legal language in support of 30-day refill quantities cannot be overstated, particularly as the primary health need of most disaster refugees is replacement prescription medications.²² It is interesting that several states with statutory provisions for only 72-hour emergency (ie, nonpublic health emergency) refill quantities have in the past instituted temporary measures allowing 30-day refill quantities in response to public health crises.^6,8,23

Pharmacy legal documents used in the analysis were available through board of pharmacy websites only. Although these sources are maintained by the boards, they may not be current or inclusive of all documents related to RPHE and pharmaceutical preparedness. Additionally, the likelihood that some material might have been overlooked in the data collection process cannot be entirely excluded, even as all board of pharmacy legal documents were reviewed multiple times to limit this possibility.

Additional variables should be identified and queried with existing data to establish a more comprehensive assessment of state pharmaceutical preparedness. For example, the existence of board policies and procedures regarding: (1) dispensing of drug samples and blood clotting agents; (2) drug distribution in emergencies; (3) waivers for controlled substance dispensing reporting; (4) closing of pharmacies without notifying boards of pharmacy, (5) public health powers of state governors; (5) tele-pharmacy subcontracting services in disasters; and (6) recruiting, training, and deploying instate pharmacist volunteers should be considered.

In light of this study and the universal availability of the RPHE, each state board of pharmacy may want to review its disaster-specific regulatory provisions to determine if current pharmaceutical preparedness language is adequate to meet the exigencies of public health emergencies. For states that discover significant gaps in this element of their preparedness blueprint, interested parties and stakeholders may need to lobby their boards of pharmacy and legislatures for the inclusion of the RPHE in their pharmacy practice acts.